MAUDE Adverse Event Report: ARTHREX, INC. GLENOID TARGETER SHAFT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	GLENOID TARGETER SHAFT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 09/05/2024, it was reported by a sales representative via (b)(4) that an ar-5400-01 vip glenoid targeter would not allow any of the arms to slide down slot c.The case was completed successfully using a back up tray without any issues.This was discovered during an rtsa procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint allegation is confirmed.Upon visual evaluation, it was noted that the edges of the vip¿ glenoid targeter titanium shaft had chipped around the edges.Functional testing was performed with matting parts and noted that they did not slide as required due to damage to the edges.The most likely cause of the reported failure can be attributed to misuse/mishandling due to damage to the device by the end user.

• Brand Name: GLENOID TARGETER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 20249208
• Report Number: 1220246-2024-07721
• Device Sequence Number: 7312521
• Product Code: KWS
• UDI-Device Identifier: 00888867315334
• UDI-Public: 00888867315334
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K222007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GLENOID TARGETER SHAFT
• Device Catalogue Number: AR-5400-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown